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Notification report


General information

Notification Number
B/SE/03/6391

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
19/12/2003

Title of the Project
Breeding of spring oilseed rape cultivars tolerant to Roundup.

Proposed period of release:
01/04/2004 to 31/10/2008

Name of the Institute(s) or Company(ies)
Svalöf Weibull AB, S-268 81 Svalöv
Sweden;


3. Is the same GMPt release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
No

Genetically modified plant

Complete name of the recipient or parental plant(s)
Common NameFamily NameGenusSpeciesSubspeciesCultivar/breeding line
spring oilseed rapebrassicaceaebrassicabrassica napusnapus (syn. oleifera)RT 73

2. Description of the traits and characteristics which have been introduced or modified, including marker genes and previous modifications:
Oilseed rape plants have been transformed with the vector pMON 17237. The genes, which have been introduced, confer to the oilseed rape plant tolerance to glyphosate, the active ingredient of the herbicide Roundup.There have been no previous genetic modifications of the parental organism.

Genetic modification

3. Type of genetic modification:
Insertion;

In case of insertion of genetic material, give the source and intended function of each constituent fragment of the region to be inserted:
A disarmed plasmid from an Agrobacterium species has been used as a vector. The vector pMON 17237 contains Roundup tolerance genes, border sequences, replication sequences and virulence genes.

The sequence to be inserted is situated between the right and left borders of the plasmid and contains combinations of the following genes:

1. A gene fusion between the chloroplast transit peptide sequence from the Arabidopsis thaliana EPSPS gene and a sequence that encodes an EPSPS enzyme similar to that of Agrobacterium sp. strain CP4. This enzyme confers Roundup tolerance in the plant.

2. A gene fusion between a transit peptide gene derived from the small subunit of Arabidopsis thaliana chloroplast transite peptide of ribulose biphosphate carboxylase and a synthetic gene sequence that encodes the glyphosate oxidoreductase enzyme (GOX). This enzyme catalyses glyphosate degradation, thus conferring Roundup tolerance in the plants.


6. Brief description of the method used for the genetic modification:
Oilseed rape plant tissue has been transformed with Agrobacterium tumefasciens containing the disarmed plasmid pMON 17237.

7. If the recipient or parental plant is a forest tree species, describe ways and extent of dissemination and specific factors affecting dissemination:
Not applicable

Experimental Release

1. Purpose of the release:
The aim of this project is to develop breeding lines with Roundup tolerance, suitable for the North American market. Notes of the agronomic performance will be made for the plots. Selected plots will be used for crosses, selfpollination and bulk harvest.

2. Geographical location of the site:
The site(s) will be in one or several of the rural districts Svalöv, Landskrona, Klippan, Höör, Hässleholm and Perstorp, Sweden, in each year. The exact location will be submitted to the competent authority each year.

3. Size of the site (m2):
Maximum 200 000 m2 each year.

4. Relevant data regarding previous releases carried out with the same GM-plant, if any, specifically related to the potential environmental and human health impacts from the release:
The same GM plant has been used in confined field trials in Sweden 1998 – 2003 (SJV dnr 22 10027/97, 22 6885/98). Staff from SW has worked in the fields throughout the growing seasons. The crop has been equivalent to other field trials, except for the tolerance to glyphosate. No observation has been made which would indicate any risk to human health, animals or environment in general.

Environmental Impact and Risk Management

Summary of the potential environmental impact from the release of the GMPts:
The genetically modified plant is substantially equivalent to normal breeding material of spring oilseed rape. Plants having the introduced character herbicide tolerance will only have a selective advantage if the herbicide is applied. Natural environments are not treated with herbicide and in the agricultural environment the plants will only have an advantage if the field is sprayed with the herbicide in question, in this case a herbicide with the active substance glyphosate.

An agronomic and economic assessment of herbicide tolerant rapeseed in Canada, made by Canola Council of Canada (2001) indicates that the transgenic herbicide tolerant varieties allow growers to use better soil management practices, which contribute to soil conservation and saved 31 million litres of fuel.


Brief description of any measures taken for the management of risks:
The distance to other fields will be at least 500 m. The sowing machine used for the modified seed will be emptied and cleaned before it is removed from the field. Remaining seed from the sowing machine will be destroyed. The fields will be surrounded by 8-m wide borders of unmodified male sterile oilseed rape to minimise spread of pollen. All volunteer plants of oilseed rape and closely related cruciferous plants, which might grow within 50 m from the outer part of the border, will be destroyed before the flowering. Beehives used will be closed for 48 hours to have the bees cleaned from viable GMO-pollen.

Combines that have been used for harvest of selected or discarded plots will be cleaned before they are removed from the field. The trial sites will be examined for volunteer plants during the following four years. Plants discovered will be destroyed before flowering. If it is a small number of plants they will be mechanically removed and larger numbers will be sprayed with effective herbicides.

After harvest spilled seed will be left on the ground to germinate. During the autumn shallow cultivation will be made. No ploughing, to minimise the risk of seed being ploughed down before it has had a chance to germinate. None of the following for crops will be oilseed rape.

Discarded seed will be taken care of for destruction by burning. Material harvested for breeding purpose will be clearly marked ‘GMO’. When seed is no longer needed it will be destroyed. Straw and other organic debris will be cut and mixed with soil in the following cultivation.

This site will be marked on a map in such a way that it will be easily found in the coming years. The site will be inspected regularly from sowing to harvest. Observations will be registered. During the following four years the site will be inspected regularly from sowing to harvest and volunteer plants destroyed.

If the trial has to be discarded because of unforeseen reasons, the plant material will be destroyed by chemical and mechanical treatment. The site will be inspected for the presence of volunteer plants the following years and such plants will be destroyed.


Summary of foreseen field trial studies focused to gain new data on environmental and human health impact from the release:
Not applicable

Final report


European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
26/04/2004 00:00:00
Remarks: